全植入式中耳换能器在连续几代产品中的可靠性演变。

Evolution of the reliability of the fully implantable middle ear transducer over successive generations.

作者信息

Debeaupte Mathilde, Decullier Evelyne, Tringali Stephane, Devèze Arnaud, Mom Thierry, Darrouzet Vincent, Truy Eric

机构信息

*Department of Otolaryngology, Hôpital E. Herriot, Université Lyon 1, Lyon, France; †Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de Recherche Clinique, Lyon, France; ‡Université de Lyon, RECIF, EAM Santé Individu Société 4128, Lyon, France; §Université Lyon 1, Lyon, France; ∥Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Département d'Oto-neurochirurgie, Pierre-Bénite, France; ¶Department of Otolaryngology, University Hospital Nord, Assistance Publique Hôpitaux de Marseille and Laboratory of Applied Biomechanics, IFSTTAR UMR T24, Aix Marseille Universités, Marseille, France; #Service ORL et Chirurgie Cervico-Faciale CHU Gabriel Montpied et laboratoire de Biophysique Neurosensorielle, INSERM UMR 1107-63000, Clermont-Ferrand, France; **ENT and Skull Base Surgery Department, Hôpital Pellegrin, Bordeaux Cedex, France; ††University of Bordeaux, Bordeaux, France; and ‡‡Lyon Neuroscience Research Center, Brain Dynamics and Cognition Team, CRNL, INSERM U1028, CNRS UMR 5292, Lyon, France.

出版信息

Otol Neurotol. 2015 Apr;36(4):625-30. doi: 10.1097/MAO.0000000000000718.

DOI:10.1097/MAO.0000000000000718

PMID:25675313

Abstract

OBJECTIVE

To describe the reliability of the fully implantable middle ear transducer after successive technological changes.

STUDY DESIGN

Prospective, observational, multicenter study.

SETTING

Eight tertiary referral centers.

PATIENTS

One hundred twenty-three adults were implanted with one of the five successive versions of the fully implantable middle ear implant between September 2005 and July 2012.

METHODS

The reliability of each generation 2 years after implantation or at the maximal lifetime was reported by means of survival curves. Only technological failures were considered; non-technological failures were excluded from the analysis of reliability.

RESULTS

One hundred fifty-seven devices were implanted during the period of study. Fifteen explantations were related to non-technological problems (e.g., infections, extrusions, etc.). One hundred forty-two implants were followed in the analysis of reliability. We observed 32 technical failures at 2 years. At the maximal lifetime of follow-up, 46 implants failed. The end of the follow-up was the first of November 2012. Survival rates at 2 years were 0%, 76.1%, 84.2%, 81.8%, and 100% for each of the successive available versions, respectively.

CONCLUSION

The reliability of the fully implantable middle ear implant improved over generations thanks to successive technological modifications that corrected the observed failures. The latest generation seems to be a reliable fully implantable middle ear implant system up to 22 months after implantation. The need to know the reliability of these active middle ear implants incites the creation of a follow-up register including patient's data and device failures to improve patient management.

摘要

目的

描述经过连续技术改进后的完全植入式中耳换能器的可靠性。

研究设计

前瞻性、观察性、多中心研究。

研究地点

八个三级转诊中心。

患者

2005年9月至2012年7月期间，123名成年人植入了五种连续版本的完全植入式中耳植入物中的一种。

方法

通过生存曲线报告各代植入物在植入2年后或最长使用期限时的可靠性。仅考虑技术故障；非技术故障排除在可靠性分析之外。

结果

研究期间共植入157个装置。15次取出与非技术问题（如感染、植入物挤出等）有关。在可靠性分析中对142个植入物进行了跟踪。我们观察到2年时有32次技术故障。在最长随访期时，46个植入物出现故障。随访截止于2012年11月1日。各连续可用版本在2年时的生存率分别为0%、76.1%、84.2%、81.8%和100%。